Characterization of the size and shape of API particles in Metered Dose Inhalation (MDI) formulations are data commonly required to demonstrate in vitro bioequivalence of a generic product to the reference drug. In this application note, we present a study comparing API particle size and shape in a generic and the innovator MDI formulations using the Morphologi® instrument. The comparison is extended to the API granules to investigate the effect of the formulation manufacturing process on the API material.
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